Proposed Registration Decision PRD2023-11, Cyclaniliprole 50SL Insecticide, Cyclaniliprole

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• Pest Management Regulatory Agency
• 13 December 2023
• ISSN: 1925-0886 (PDF version)
• Catalogue number: H113-9/2023-11E-PDF (PDF version)

Summary

Table of contents

• Proposed registration decision for Cyclaniliprole 50SL Insecticide
• What does Health Canada consider when making a registration decision?
• What is cyclaniliprole?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other information

Proposed registration decision for Cyclaniliprole 50SL Insecticide

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act, is proposing registration for the sale and use of Cyclaniliprole 50SL Insecticide, containing the technical grade active ingredient cyclaniliprole, as a foliar insecticide for use on greenhouse tomato for control or suppression of western flower thrips, whiteflies, beet armyworm, bertha armyworm, cabbage looper and fall armyworm; greenhouse pepper for suppression of pepper weevil; greenhouse ornamentals for the suppression of western flower thrips and onion thrips and outdoor ornamentals for the suppression of redheaded flea beetle. This evaluation was completed under the User Requested Minor Use Label Expansion program, which is a cooperative program between Agriculture and Agri-Food Canada and Health Canada's Pest Management Regulatory Agency and includes participation by sponsor groups, manufacturers, and both provincial and federal governments.

The end use product, Cyclaniliprole 50SL Insecticide, and the active ingredient, cyclaniliprole, are currently registered for the control of various insect pests on a variety of field grown vegetable, tree nut and fruit crops. For details, see Proposed Registration Decision PRD2017-12, Cyclaniliprole and Cyclaniliprole 50SL Insecticide, and Registration Decision RD2017-17, Cyclaniliprole and Cyclaniliprole 50SL Insecticide.

An evaluation of available scientific information found that, under the approved conditions of use, the health and environmental risks and the value of Cyclaniliprole 50SL, containing cyclaniliprole, are acceptable.

This summary describes the key points of the evaluation, while the Science evaluation of Proposed Registration Decision PRD2023-11, Cyclaniliprole 50SL Insecticide, Cyclaniliprole provides detailed technical information on the human health, environmental and value assessments of Cyclaniliprole 50SL Insecticide, containing cyclaniliprole, when applied to outdoor and greenhouse ornamentals, greenhouse pepper and greenhouse tomato.

What does Health Canada consider when making a registration decision?

The key objective of the Pest Control Products Act is to prevent unacceptable risks to people and the environment from the use of pest control products. Health or environmental risk is considered acceptable^{Footnote 1} if there is reasonable certainty that no harm to human health, future generations or the environment will result from use or exposure to the product under its proposed conditions of registration.

The Act also requires that products have value^{Footnote 2} when used according to the label directions. Conditions of registration may include special precautionary measures on the product label to further reduce risk.

To reach its decisions, the PMRA applies modern, rigorous risk-assessment methods and policies. These methods consider the unique characteristics of sensitive subpopulations in humans (for example, children) as well as organisms in the environment. These methods and policies also consider the nature of the effects observed and the uncertainties when predicting the impact of pesticides. For more information on how the Health Canada regulates pesticides, the assessment process and risk-reduction programs, please visit the Pesticides section of Canada.ca.

Before making a final registration decision on Cyclaniliprole 50SL Insecticide, containing cyclaniliprole, Health Canada's PMRA will consider any comments received from the public in response to this consultation document.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on Cyclaniliprole 50SL Insecticide, containing cyclaniliprole, which will include the decision, the reasons for it, a summary of comments received on the proposed registration decision and Health Canada's response to these comments.

For more details on the information presented in this summary, please refer to the Science evaluation of this PRD2023-11.

What is cyclaniliprole?

Cyclaniliprole is a member of the diamide group of insecticides that affects certain receptors in insect muscle, causing paralysis and death. Cyclaniliprole is the active ingredient in the end-use product Cyclaniliprole 50SL Insecticide. Cyclaniliprole 50SL Insecticide is applied via foliar applications to control or suppress a variety of pests on certain crops.

Health considerations

Can approved uses of cyclaniliprole affect human health?

Cyclaniliprole 50SL Insecticide, containing cyclaniliprole, is unlikely to affect your health when used according to label directions.

Potential exposure to cyclaniliprole may occur through the diet (food and drinking water), when handling and applying the end-use product, or when entering an area that has been treated with the product. When assessing health risks, two key factors are considered: the levels where no health effects occur and the levels to which people may be exposed. The dose levels used to assess risks are selected to protect the most sensitive human population (for example, children and nursing mothers). As such, sex and gender are taken into account in the risk assessment. Only uses for which the exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.

Toxicology studies in laboratory animals describe potential health effects from varying levels of exposure to a chemical and identify the dose level at which no effects are observed. The health effects noted in animals occur at dose levels more than 100-times higher (and often much higher) than levels to which humans are normally exposed when pesticide products are used according to label directions.

In laboratory animals, the technical grade active ingredient cyclaniliprole was of low acute toxicity by the oral, dermal, and inhalation routes of exposure. It was non-irritating to the skin and eyes and did not cause an allergic skin reaction.

The end-use product, Cyclaniliprole 50SL Insecticide, was of low acute toxicity by the oral, dermal, and inhalation routes of exposure. It was minimally irritating to the eyes and non-irritating to the skin and did not cause an allergic skin reaction.

Registrant-supplied short- and long-term (lifetime) animal toxicity tests, as well as information from the published scientific literature, were assessed for the potential of cyclaniliprole to cause neurotoxicity, immunotoxicity, genetic damage, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoints for risk assessment were effects on the liver. There was no evidence that the young were more sensitive to cyclaniliprole than the adult animal.

The risk assessment protects against the effects noted above and other potential effects by ensuring that the level of exposure to humans is well below the lowest dose at which these effects occurred in animal tests.

Residues in water and food

Dietary risks from food and drinking water are not of health concern.

Aggregate dietary intake estimates (food plus drinking water) revealed that the general population and children 1–2 years old, the subpopulation which would ingest the most cyclaniliprole relative to body weight, are expected to be exposed to less than 7% of the acceptable daily intake. Based on these estimates, the chronic dietary risk from cyclaniliprole is not of health concern for all population subgroups.

Cyclaniliprole is not carcinogenic; therefore, a cancer dietary risk assessment is not required.

Animal studies revealed no acute health effects. Consequently, a single dose of cyclaniliprole is not likely to cause acute health effects in the general population (including infants and children).

The Food and Drugs Act prohibits the sale of adulterated food, that is, food containing a pesticide residue that exceeds the established maximum residue limit (MRL). Pesticide MRLs are established for Food and Drugs Act purposes through the evaluation of scientific data under the Pest Control Products Act. Food containing a pesticide residue that does not exceed the established MRL does not pose an unacceptable health risk.

Residue trials conducted throughout Canada and the United States using cyclaniliprole on greenhouse peppers and tomatoes are acceptable. The MRLs for this active ingredient can be found in the Science evaluation of this consultation document.

Occupational risks from handling Cyclaniliprole 50SL Insecticide

Occupational risks are not of concern when Cyclaniliprole 50SL is used according to the proposed label directions, which include protective measures.

Workers mixing, loading, or applying Cyclaniliprole 50SL, and workers entering recently treated areas, can be exposed to cyclaniliprole residues through direct skin contact or through inhalation. Therefore, the label specifies that anyone mixing, loading, and applying Cyclaniliprole 50SL must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes. The label also requires that workers do not enter or be allowed into treated areas during the restricted-entry interval (REI) of 12 hours. Taking into consideration the label statements, the number of applications and the duration of exposure for handlers and postapplication workers, the risks to these individuals are not of health concern when Cyclaniliprole 50SL is used according to the proposed label directions.

Risks in residential and other non-occupational environments

Risks in residential and other non-occupational environments are not of health concern when Cyclaniliprole 50SL is used according to the proposed label directions and REIs are observed.

Residential risks from exposure to Cyclaniliprole 50SL when contacting treated ornamentals, such as trees and shrubs, following commercial application to outdoor ornamentals in residential areas are not of health concern.

Health risks to bystanders

Bystander risks are not of health concern when Cyclaniliprole 50SL is used according to the proposed label directions and spray drift restrictions are observed.

A standard label statement to protect against drift during application is on the label. Therefore, health risks to bystanders are not of concern when the end-use product is used according to the proposed label directions.

Environmental considerations

When used according to label directions, the environmental risks associated with the major new uses of cyclaniliprole and its associated end-use product, Cyclaniliprole 50SL Insecticide, on outdoor ornamentals, greenhouse ornamentals and greenhouse food crops are acceptable.

The environmental impact of the use of cyclaniliprole in field crops was evaluated in Proposed Registration Decision PRD2017-12, Cyclaniliprole and Cyclaniliprole 50SL Insecticide, and Registration Decision RD2017-17, Cyclaniliprole and Cyclaniliprole 50SL Insecticide. Cyclaniliprole is toxic to aquatic organisms, bees and other beneficial insects. Risk mitigation measures for these organisms are present on the registered label of Cyclaniliprole 50SL Insecticide.

The proposed major new uses of cyclaniliprole include application to outdoor ornamental plants, greenhouse ornamental plants and greenhouse food crops. It is possible that ornamental plants treated in greenhouses could be moved outside following application of cyclaniliprole. The proposed major new uses of cyclaniliprole are not expected to increase the environmental exposure of non-target organisms to cyclaniliprole compared to the registered use in field crops when label directions are followed. Restrictions on application timing for ornamental plants that are treated outside, or plants that are treated in greenhouses and then moved outside, are required to minimize exposure to bees.

The use of cyclaniliprole in greenhouses could result in adverse effects to bees and other beneficial insects used in greenhouse production. A label statement to inform users to avoid application of cyclaniliprole when bees and other beneficial insects are in the treatment area is required.

After a scientific review of the available information, the PMRA has concluded that the environmental risks associated with the major new uses of cyclaniliprole in outdoor ornamentals, greenhouse ornamentals and greenhouse food crops are acceptable when Cyclaniliprole 50SL Insecticide is used according to label directions.

Value considerations

What is the value of Cyclaniliprole 50SL Insecticide?

Cyclaniliprole 50SL Insecticide provides control or suppression of western flower thrips, whiteflies, beet armyworm, bertha armyworm, cabbage looper and fall armyworm on greenhouse tomatoes. The registration of Cyclaniliprole 50SL Insecticide for these uses will provide the first insecticide product to manage bertha armyworm and fall armyworm on greenhouse tomatoes, as well as an alternative product for use to manage the other listed pests.

Cyclaniliprole 50SL Insecticide provides suppression of pepper weevil on greenhouse peppers. The registration of Cyclaniliprole 50SL Insecticide for this use will provide greenhouse pepper growers with an alternative product for use to manage pepper weevil.

Cyclaniliprole 50SL Insecticide provides suppression of western flower thrips and onion thrips on greenhouse ornamentals. Cyclaniliprole is a new active ingredient for this use, which was identified as a priority for Canadian growers. Thrips are known for developing resistance to pesticides, so having many active ingredients available is important for resistance management.

Cyclaniliprole 50SL Insecticide provides suppression of redheaded flea beetle on outdoor ornamentals (excluding confiders). This will be the first insecticide product registered for this use in Canada.

Measures to minimize risk

Labels of registered pesticide products include specific instructions for use. Directions include risk-reduction measures to protect human health and the environment. These directions must be followed by law.

The key risk-reduction measures being proposed on the label of Cyclaniliprole 50SL Insecticide to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures - Human health

To reduce the potential exposure of workers to cyclaniliprole through direct skin contact or inhalation of sprays, workers mixing, loading and applying Cyclaniliprole 50SL and performing cleaning and repair activities must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes.

The label also requires that workers do not enter or be allowed entry into treated areas during the REI of 12 hours. Furthermore, standard label statements to protect against drift during application and to prevent the use of handheld airblast, mistblowers and foggers are present on the label.

Key risk-reduction measures - Environment

The following new risk mitigation measures are required:

Greenhouse uses:

• Label statement to inform users to avoid application of cyclaniliprole when bees and other beneficial insects used in greenhouse production are in the treatment area.
• Label statement to prohibit the movement of bee-attractive plants outdoors if flowers that have been sprayed with cyclaniliprole remain on the plant.
• Label statement prohibiting the discharge of greenhouse releases, effluent or runoff to water.

Outdoor ornamentals:

• Label statement restricting application to the evening for bee attractive plants that are in bloom.
• Spray buffer zones of 1 metre to protect aquatic habitat.

Next steps

Before making a final registration decision on Cyclaniliprole 50SL Insecticide, Health Canada's PMRA will consider any comments received from the public in response to PRD2023-11. Health Canada will accept written comments on this proposal up to 45 days from the date of publication of PRD2023-11. Please note that, to comply with Canada's international trade obligations, consultation on the proposed MRLs will also be conducted internationally via a notification to the World Trade Organization. Please forward all comments to Publications. Health Canada will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed decision and Health Canada's response to these comments.

Other information

When Health Canada makes its registration decision, it will publish a Registration Decision on Cyclaniliprole 50SL Insecticide, containing cyclaniliprole (based on the Science evaluation of PRD2023-11). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room. For more information, please contact the PMRA's Pest Management Information Service.